Repeated Educational Intervention for the Prevention of Diabetic Foot Ulcers in High-risk Patients

Not Applicable

Terminated

• Conditions: Diabetic Foot
• Interventions: Behavioral: Single session; Behavioral: Repeated intervention

• Registration Number: NCT03555656
• Lead Sponsor: Azienda Ospedaliero-Universitaria Careggi

Brief Summary

Following a prior observation that a brief structured group educational intervention is effective for the prevention of diabetic foot ulcers in high-risk patients, but that the efficacy decreases over the time, this study is designed to verify the effect of a repetition of the educational intervention.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-01
• Study First Submitted: 2018-06-01
• Study First Submitted QC: 2018-06-01
• Study First Posted: 2018-06-13
• Primary Completion: 2019-07-10
• Study Completion: 2019-07-10
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-12
• Last Update Posted: 2021-01-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 89

Inclusion Criteria

• Type 2 diabetes mellitus
• Either diabetic neuropathy or previous foot ulcer

Exclusion Criteria

• Arteriopathy of lower limbs, with ABI<0.8 or needing revascularization

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Single session	Initial single group educational session, with no repetition
Repeated educational intervention	Repeated intervention	Repetition every 6 months of a group educational session

Primary Outcome Measures

Name	Time	Method
Incidence of foot ulcers	24 months

Secondary Outcome Measures

Name	Time	Method
Incidence of foot ulcers	6 months
incidence of foot ulcers	12 months

Trial Locations

Locations (1)

Diabetologia AOU Careggi; 🇮🇹 Florence, Italy